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Revolutionize SaMD development: Agile meets IEC 62304

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Oct 20, 2023

7 min read

samd series | author

Weronika Michaluk

Digital Health Principal
SaMD Lead at HTD Health

Software as a Medical Device (SaMD) is changing the landscape of healthcare, allowing for innovative solutions that improve patient care and outcomes. However, SaMD development is a complex process that has to follow various regulations to ensure safety and efficacy. This is where the IEC 62304 standard comes into play.

IEC 62304 is an international standard that outlines the life cycle requirements for medical device software. It provides a common framework for software development, aiming to ensure the safety and effectiveness of the software in medical devices.

This standard covers the processes, activities, and tasks needed to develop, maintain, and manage medical software, making sure that it meets regulatory and quality requirements. Following IEC 62304 is crucial for developers and companies in the medical device field to ensure that their products are safe, effective, and compliant with regulatory expectations.

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Why the SaMD industry should follow IEC 62304

Recognized by the FDA, this is the go-to standard for medical device software development that provides a framework for the software life cycle processes of SaMD. It’s applicable to a wide range of SaMD, from health monitoring apps to complex diagnostic software.

While it’s not globally mandatory to follow IEC 62304, doing so aligns well with FDA guidance on SaMD and makes the approval process more straightforward. So, whether you’re new to the field or part of a seasoned team at a SaMD company, adhering to the current version of IEC 62304 is crucial for successful and agile SaMD development.

Agile development

In the dynamic landscape of medical device development, adopting an Agile approach isn’t just a modern trend, but a foundation to delivering safe, efficient, and user-friendly Software as a Medical Device (SaMD). The IEC 62304 lays down the framework for software life cycle processes with a focus on safety and effectiveness of SaMD.

The clue lies in understanding how to develop software as a medical device in an Agile but also compliant way. Let’s delve into a real-world example to underline the benefits of Agile in SaMD development.

Real-world example: Development of a diabetes management app

Revolutionize SaMD Development - Diabetes Management App

Let’s use a Diabetes Management App as an example of how an Agile framework can be helpful: Let’s say there is a device company building a new smart insulin pump device with accompanying mobile application. This app would help patients track their blood sugar levels, manage how much insulin they take, and provide advice on what to eat.

Agile software design and development allows product teams to work in iterative cycles, incorporating feedback and new learnings throughout a project rather than strictly defining needs up front and executing in a vacuum. This approach can have many benefits:

  • Improved Safety through Continuous Testing: If there’s a bug that causes incorrect insulin dosage suggestions, Agile’s continuous testing can catch this early. This way, developers can fix the issue before it reaches patients, thus preventing potential health risks.
  • Enhanced User Experience through Regular Feedback: Suppose patients find it difficult to enter their daily carbohydrate intake due to a cumbersome interface. Agile allows for prompt feedback collection and action, thus the interface can be simplified in the next sprint, making the app more user-friendly.
  • Up-to-Date Medical Information: If new research reveals a better way to manage blood sugar levels, Agile allows for quick updates to the app to include this new information, ensuring patients have access to the latest recommendations.
  • Better Compliance with Regulatory Requirements: IEC 62304 requires detailed documentation of software development processes. Agile’s emphasis on maintaining updated documentation every sprint helps in fulfilling this requirement, ensuring traceability and compliance.
  • Enhanced Patient Education Features: Feedback from users could indicate a need for more educational content within the app. Agile allows for the integration of such featuresin subsequent sprints, thus providing better support to patients in managing their diabetes.

Can Agile really meet IEC 62304 requirements?

As we described in a previous article about Agile development, it may seem that Agile—with its focus on working software over comprehensive documentation may not fit with the strict regulatory demands of SaMD, where extensive documentation is often required. But, when we look closer, we can see that Agile and SaMD can work together beautifully.

First, let’s understand that ‘working software over comprehensive documentation’ does not mean ‘working software without any documentation’. The principle emphasizes that, while Agile teams do produce the necessary documentation, they prioritize delivering working software that adds value to the users.

The iterative nature of Agile development, with its regular feedback loops, can actually improve the quality of the documentation required for SaMD.

In Compliant Agile methodology, documentation evolves along with the software, making it more accurate and up-to-date. Instead of a heavy upfront documentation process, Agile encourages the creation of ‘living documents’ that grow and adapt alongside the product.

Step by step guide for Agile SaMD development compliant with IEC 62304

Integration of IEC 62304’s requirements for medical device software into the Agile development process can be very challenging. This process begins from the macro perspective and then breaks down into more granular components: individual releases, sprints/iterations, and finally, individual user stories. At each level, distinct aspects of the IEC 62304 are addressed.

Soon, we will release step by step guide on how to lead your SaMD project in an Agile way that is compliant with IEC 62304. You will discover the perfect blend of Agile flexibility and IEC 62304 compliance in SaMD development through our insightful guide. We will uncover the step-by-step integration of Agile Scrum events with IEC 62304 clauses, right from the overarching project level down to individual user stories.

This invaluable resource illustrates how you can harness the iterative power of Agile while ensuring rigorous regulatory compliance. After reading this guide you will understand how continuous testing, and iterative feedback, incorporated within a compliant framework, can significantly improve the quality, safety, and market relevance of your SaMD projects.

Don’t miss out on this golden opportunity to elevate your SaMD development game to new heights. Sign up for our newsletter and be up-to-date with all the SaMD releases to embark on a journey towards mastering compliant Agile development in SaMD.

Your pathway to developing compliant, and user-centric SaMD begins here!

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